Esposito M, Worthington H V, Thomsen P, Coulthard P
Department of Biomaterials and Department of Prosthetic Dentistry/Dental Material Sciences, Sahlgrenska Academy at Goteborg University, PO Box 412, Medicinaregatan 8B, Goteborg, Sweden, SE-405 30.
Cochrane Database Syst Rev. 2004(3):CD003878. doi: 10.1002/14651858.CD003878.pub2.
To minimize the risk of implant failure, osseointegrated oral implants are conventionally kept load-free during the healing period. During healing removable prostheses are used, however many patients find these temporary prostheses rather uncomfortable and it would be beneficial if the healing period could be shortened without jeopardizing implant success. Nowadays immediate and early loaded implants are commonly used in mandibles of good bone quality. It would be useful to know whether there is a difference in success rates between immediately or early loaded implants compared with conventionally loaded implants.
To test the null hypothesis of no difference in the clinical performance between osseointegrated implants loaded at different times 1 year after loading.
The Cochrane Oral Health Group's Trials Register, The Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE were searched. Handsearching included several dental journals. Authors of all identified trials, an internet discussion group and 55 oral implant manufacturers were contacted to find unpublished randomized controlled trials (RCTs). The last electronic search was conducted on 2 February 2004.
All RCTs of root-form osseointegrated oral implants having a follow up of at least 1 year comparing the same osseointegrated root-form oral implants loaded at different times.
Data were independently extracted, in duplicate, by two reviewers. Authors were contacted for details of randomization and withdrawals and a quality assessment was carried out. The Cochrane Oral Health Group's statistical guidelines were followed.
Seven RCTs were identified and five trials including 124 patients in total were suitable for inclusion. Implants have been either immediately loaded after insertion (2 to 3 days), early loaded (6 weeks) or conventionally loaded (3 to 8 months) in edentulous mandibles of adequate bone quality and shape. On a patient, rather than per implant basis, there were no statistically significant differences for prosthesis failures, implant failures and marginal bone loss on intra-oral radiographs.
REVIEWERS' CONCLUSIONS: While it is possible to successfully load oral implants immediately after their placement in mandibles of adequate bone density and height of carefully selected patients, it is yet unknown how predictable this approach is. More well designed RCTs are needed to understand how predictable immediate and early loading are. Such trials should be simply designed and should be reported according to the CONSORT guidelines (http://www.consort-statement.org/). It is suggested that priority should be given to trials assessing the effectiveness of immediately loaded implants rather than early loaded ones.
为将种植体失败的风险降至最低，传统上骨结合式口腔种植体在愈合期需保持无负载状态。在愈合期间使用可摘义齿，然而许多患者觉得这些临时义齿相当不舒服，并且如果能在不危及种植成功的前提下缩短愈合期将会有益。如今，即刻负载和早期负载种植体常用于骨质良好的下颌骨。了解即刻或早期负载种植体与传统负载种植体的成功率是否存在差异将很有帮助。
检验在负载1年后，不同时间负载的骨结合式种植体临床性能无差异这一无效假设。
检索了Cochrane口腔健康组试验注册库、Cochrane对照试验中央注册库、MEDLINE和EMBASE。手工检索包括几本牙科杂志。联系了所有已识别试验的作者、一个互联网讨论组和55家口腔种植体制造商，以查找未发表的随机对照试验（RCT）。最后一次电子检索于2004年2月2日进行。
所有根形骨结合式口腔种植体的RCT，随访至少1年，比较相同的在不同时间负载的根形骨结合式口腔种植体。
由两名评价员独立提取数据，一式两份。联系作者获取随机分组和撤组的详细信息，并进行质量评估。遵循Cochrane口腔健康组的统计指南。
识别出7项RCT，5项试验共124例患者适合纳入。在骨质和形状合适的无牙下颌骨中，种植体在植入后即刻（2至3天）、早期（6周）或传统方式（3至8个月）负载。以患者而非单个种植体为基础，在义齿失败、种植体失败以及口腔内X线片上的边缘骨丢失方面，无统计学显著差异。
虽然在精心挑选的骨密度和高度合适的下颌骨患者中，种植体植入后即刻成功负载是可能的，但这种方法的可预测性尚不清楚。需要更多设计良好的RCT来了解即刻和早期负载的可预测性如何。此类试验应设计简单，并应按照CONSORT指南（http://www.consort-statement.org/）进行报告。建议优先进行评估即刻负载种植体而非早期负载种植体有效性的试验。
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